Monday, August 15, 2011

CMS AMPlifies Anxiety As Industry Wrestles With Non-Guidance

“MDRP Perspectives” Explores Impending AMP Ruling Implications: How To Do When All You Know Is What Not To Do?

By Marc Dresner, IIR USA

A veteran attorney and lobbyist for the pharmaceutical industry once told me that the name of the Bill speaks volumes: Whatever the title says, the inference is that the industry targeted has been doing the opposite.

Consider the Patient Protection and Affordable Care Act passed in March 2010. Based on counsel’s insight, that’s pretty cynical rhetoric.

A more appropriate title might've been the Calculation Crystal Clarity Act, because for the second time in just four years (the first being 2007’s Deficit Reduction Act) the US government turned AMP calculation into a guesswork methodology.

Jennifer Norton, iMany
According to Jennifer Norton, Senior Director of Life Sciences Strategy and Solutions at iMany—a contract performance management solutions provider—CMS has done an admirable job of telling manufacturers what not to do since 2010, but they’ve been rather vague when it comes to guidance on what to do.

As a result, manufacturers are banging their heads against the wall trying to comply with rules that to date only exist in CMS’s imagination.

But there’s a light at the end of the tunnel: CMS is expected to issue an AMP ruling soon, and chances are whatever you’re currently doing may not be completely wrong.

In this episode of MDRP Perspectives, Norton provides a comprehensive overview of the situation, identifies potential potholes to watch out for, and offers sound advice on how to best avoid becoming a casualty of well-intentioned, ham-handed regulation.

Just bear in mind that getting direction from CMS is like asking what’s the fastest route from New York to Honolulu and being told not to walk…

Listen to the podcast here.

Download the transcript here.

Author’s note: Jennifer Norton will be speaking on “New Contract Management Strategies and Practices Following Healthcare Reform” at the 16th Annual Summit on the Medicaid Drug Rebate Program (MDRP) September 14-16 in Chicago.

For more information or to register, please visit

And for further background and a good chuckle, check out Jen Norton’s stint as field correspondent covering the government pricing nerd uprising at CMS headquarters in Baltimore here.

Marc Dresner is an IIR USA communication lead with a background in trade journalism and marketing. He is the former executive editor of Pharma Market Research Report, a confidential newsletter for market research professionals specializing in the pharmaceutical, biotech and health care industries. He may be reached at Follow him @mdrezz.

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